10-LANGUAGE TRANSLATION AND HARMONIZATION OF THE INTERNATIONAL PROSTATE SYMPTOM SCORE - DEVELOPING A METHODOLOGY FOR MULTINATIONAL CLINICAL-TRIALS

Objective: Production of cross-culturally adapted and harmonized trans lations of the International Prostate Symptom Score (I-PSS) into 10 la nguages (Canadian French, Danish, Dutch, Flemish, French, German, Ital ian, Norwegian, Spanish, Swedish) by means of an appropriate methodolo gy. Methods: A method based on state-of-the-art guidelines about trans lation of questionnaires was developed which consisted of forward-tran slation, rating for clarity, common language and cultural adequacy, gr oup discussion and consensus, testing for comprehension in lay subject s, back-translation and rating for conceptual equivalence. Results: Th e study lasted 3 months. Items 1-7 scored high for clarity, common lan guage and cultural adequacy (mean range 5.3-9.8) as also did item 8 (5 .1-9.7). Only 10% of items were rated less than 5.0. Comprehension tes ts in lay subjects produced comments in 10% of items, most frequently in items 2, 7, and 8, and response categories for items 1-6, Compariso ns between the back-translations and the source version showed that 84 % of all items, 88% of response categories for items 1-6, 100% of resp onse categories for item 7; and 75% of response categories from item 8 were conceptually equivalent. Conclusion: The present set of 10 trans lations plus the original I-PSS questionnaire can be used in multi-cou ntry studies in which benign prostatic hyperplasia symptoms are to be assessed using the I-PSS and the data collected from different countri es can be legitimately aggregated.